Endobiliary RFA for Unresectable Malignant Biliary Strictures

RFA is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. It uses bipolar electrical energy for tissue coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography (ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit for controlling tumour growth. Several cohort studies have been published and the feasibility and safety of such technique has been proved.

The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in patients with unresectable cholangiocarcinoma or ampullary carcinoma.

The objectives are

• To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients' survival as compared to the only stenting therapy.
• To assess the impact of RFA on the stent's patency.

Inclusion criteria

• Either gender greater than or equal to 18 years of age.
• Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
• Biliary obstruction, Bilirubin > 40umol/L at diagnosis
• Subjects capable of giving informed consent
• Life expectancy of at least 3 months
• Histologically (preferred) or radiologically confirmed cholangiocarcinoma or ampullary cancer

Exclusion criteria

• Cardiac Pacemaker
• Patient unstable for endoscopy
• Inability to give informed consent
• Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
• Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
• Active suppurative cholangitis
• Complex stenoses will not be eligible for the trial
• Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
• Malignant ascites
• Presence of main portal vein thrombosis
• Prior stents placement
• Prior Billroth II or roux-en Y reconstruction
• Inability to insert a guide wire across the malignant stricture
• Pregnancy
• Presence of other malignancy
• Life expectancy < 3months